SUNBETTER BROAD SPECTRUM SPF 68 SUNSCREEN COMPACT TONE SMART- zinc oxide, titanium dioxide stick

United States - English - NLM (National Library of Medicine)

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Active ingredient:
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Available from:
SKINBETTER SCIENCE LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - Helps prevent sunburn. - If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Authorization status:
OTC monograph not final
Authorization number:
73291-0001-1

SUNBETTER BROAD SPECTRUM SPF 68 SUNSCREEN COMPACT TONE SMART- zinc

oxide, titanium dioxide stick

SKINBETTER SCIENCE LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Drug Facts

Active ingredients

Titanium Dioxide 8.4%

Zinc Oxide 10.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin

cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

right away.

Directions

Apply liberally and evenly 15 minutes before sun exposure.

Reapply:

after 80 minutes of swimming or sweating.

immediately after towel drying.

at least every 2 hours.

use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early

skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15

or higher and other sun protection measures including:

limit time in the sun, especially from 10 a.m. - 2 p.m.

wear long-sleeved shirts, pants, hats and sunglasses.

Children under 6 months of age: Ask a doctor.

Inactive ingredients

1,2-Hexanediol, Acrylates/Dimethicone Copolymer, Alumina, Bis-Vinyl Dimethicone/Dimethicone

Copolymer, Bisabolol, Brassica Campestris (Rapeseed) Sterols, Butyloctyl Salicylate, Caprylic/Capric

Triglyceride, Caprylyl Glycol, Cerium Oxide, Cetylhydroxyproline Palmitamide, Dimethicone,

Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Ethylhexylglycerin,

Hexyldecanol, Himanthalia Elongata Extract, Hydrogenated Vegetable Oil, Iron Oxides (CI 77491, CI

77492, CI 77499), Laureth-25, Laureth-3, Mica, Octyldodecyl Neopentanoate, Ozokerite, Phenethyl

Alcohol, Phenoxyethanol, Phenyl Trimethicone, Plankton Extract, Polyethylene, Polyhydroxystearic

Acid, Polymethyl Methacrylate, Prunus Armeniaca (Apricot) Kernel Oil, Silica, Simethicone, Sodium

Chloride, Stearic Acid, Tocopherol, Tocopheryl Acetate, Tribehenin, Triethoxycaprylylsilane, Vinyl

Dimethicone/Methicone Silsesquioxane Crosspolymer, Water, Zingiber Officinale (Ginger) Root

Extract.

Other information

Protect this product from excessive heat and direct sun.

Questions or comments?

800-538-5600

Principal Display Panel

sun better™

Advanced Mineral Protection

BROAD SPECTRUM SPF 68

SUNSCREEN COMPACT

TONE SMART

Water-Resistant (80 Minutes)

Mineral Actives

skinbetter science

Net wt. 0.42 oz (12g)

Peel Here

SUNBETTER BROAD SPECTRUM SPF 68 SUNSCREEN COMPACT TONE

SMART

zinc oxide, titanium dioxide stick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7329 1-0 0 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

8 4 mg in 1 g

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

10 0 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

.ALPHA.-BISABO LO L, ( +/-) - (UNII: 36 HQN158 VC)

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

CERIC O XIDE (UNII: 6 19 G5K328 Y)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TRIBEHENIN (UNII: 8 OC9 U7TQZ0 )

VINYL DIMETHICO NE/METHICO NE SILSESQ UIO XANE CRO SSPO LYMER (UNII: 9 NH1UDD2RR)

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

DISTEARDIMO NIUM HECTO RITE (UNII: X6 8 7XDK0 9 L)

PO LY( METHYL METHACRYLATE; 4 50 0 0 0 MW) (UNII: Z47NNT4J11)

APRICO T KERNEL O IL (UNII: 54JB35T0 6 A)

.ALPHA.-TO CO PHERO L, DL- (UNII: 7QWA1RIO0 1)

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

LAURETH-2 5 (UNII: RPD530 41LR)

LAURETH-3 (UNII: F32E4CB0 UJ)

O CTYLDO DECYL NEO PENTANO ATE (UNII: X8 725R8 8 3T)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

HIGH DENSITY PO LYETHYLENE (UNII: UG0 0 KM4WR7)

DIMETHICO NE METHACRYLATE ( 3 0 0 0 MW) (UNII: LO1KC6 D3D5)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

RAPESEED STERO L (UNII: B46 B6 DD20 U)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

CERESIN (UNII: Q1LS2UJO3A)

PO LYHYDRO XYSTEARIC ACID ( 2 3 0 0 MW) (UNII: YXH47AOU0 F)

MICA (UNII: V8 A1AW0 8 8 0 )

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

WATER (UNII: 0 59 QF0 KO0 R)

GINGER (UNII: C5529 G5JPQ)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

SKINBETTER SCIENCE LLC

DIMETHICO NE/VINYL DIMETHICO NE CRO SSPO LYMER ( SO FT PARTICLE) (UNII: 9 E4CO0 W6 C5)

CO RN O IL (UNII: 8 470 G57WFM)

HEXYLDECANO L (UNII: 151Z7P1317)

CETYLHYDRO XYPRO LINE PALMITAMIDE (UNII: 74ONU0 S6 2G)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

HIMANTHALIA ELO NGATA (UNII: 21RND18 XRR)

PHENYLETHYL ALCO HO L (UNII: ML9 LGA746 8 )

PHENYL TRIMETHICO NE (UNII: DR0 K5NOJ4R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7329 1-0 0 0 1-1 12 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 3/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 9 /0 3/20 19

Labeler -

SKINBET T ER SCIENCE LLC (049403602)

Revised: 8/2019

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