AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF30 EARTHWELL ZINC TECHNOLOGY, REEF SAFE- zinc oxide lotion

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

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Active ingredient:
Zinc Oxide 19%
Available from:
Amavara, Inc
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. Retains SPF after 80 minutes activity in the water, sweating or perspiring. Provides high protection against sunburn.
Authorization status:
OTC monograph final
Authorization number:
71942-101-01, 71942-101-03

AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF30 EARTHWELL ZINC

TECHNOLOGY, REEF SAFE- zinc oxide lotion

Amavara, Inc

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.

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AMAVARA TRANSPARENT MINERAL SUNSCREEN LOTION SPF30

EARTHWELL ZINC TECHNOLOGY, REEF SAFE

Drug Facts

Active Ingredients

Zinc Oxide 19%

Purpos e

Sunscreen

Us es

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. Retains SPF after 80 minutes

activity in the water, sweating or perspiring. Provides high protection against sunburn.

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 or iritation develops and lasts.

Keep out of reach of children

If Product is swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply liberally and generously 15 minutes before sun exposure and at least every 2 hours

Children under 6 months of age, ask doctor

Reapply :

after 80 minutes of swimming or sweating

immediately after towel drying

at least after every 2 hours

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

®

®

Wear long sleeved shirts, pants, hats, and sunglasses.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Water, Butyloctyl Salicylate, Polyglyceryl-3 Sorbityl Linseedate, Styrene/Acrylates Copolymer,

Dimethicone, Cetyl Dimethicone, Caprylic/Capric Triglyceride , Silica, Phenyl Trimethicone,

Polyhydroxystearic Acid, Sodium Chloride, Caramel, Hydroxyacetophenone, Disteardimonium,

Hectorite, 1,2-Hexanediol , Caprylyl Glycol, Polymethylmethacrylate, Tocopheryl Acetate, Triethyl

Citrate, Glycerin, Bisabolol, Acrylates/Dimethicone Copolymer, Benzylidene

Dimethoxydimethylindanone, Cerium Oxide, Aluminum Oxide, Zingiber Officinale (Ginger) Root

Extract

PRINCIPAL DISPLAY PANEL - 49 mL Tube Label

AMAVARA

REEF SAFE

SPF 30

+ EarthWell

Zinc Technology

Transparent Mineral Sunscreen

Safe for Sensitive Skin

Broad Spectrum SPF 30

Water Resistant (80 Minutes)

1.65 FL. OZ. / 49 mL

Reef Safe

Cruelty Free

Child Friendly

Dry Grip

AMAVARA TRANSPARENT MINERAL SUNSCREEN SPF30 EARTHWELL ZINC

TECHNOLOGY, REEF SAFE

zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:719 42-10 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

ZINC OXIDE

19 0 mg in 1 mL

Inactive Ingredients

Amavara, Inc

Ingredient Name

Stre ng th

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

TRIETHYL CITRATE (UNII: 8 Z9 6 QXD6 UM)

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

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

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

GLYCERIN (UNII: PDC6 A3C0 OX)

GINGER (UNII: C5529 G5JPQ)

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

BENZYLIDENE DIMETHO XYDIMETHYLINDANO NE (UNII: 75HIF3C9 7L)

CERIC O XIDE (UNII: 6 19 G5K328 Y)

PHENYL TRIMETHICO NE (UNII: DR0 K5NOJ4R)

CARAMEL (UNII: T9 D9 9 G2B1R)

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

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

HYDRO XYACETO PHENO NE (UNII: G1L3HT4CMH)

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

LEVO MENO L (UNII: 24WE0 3BX2T)

WATER (UNII: 0 59 QF0 KO0 R)

CETYL DIMETHICO NE 2 5 (UNII: U4AS1BW4ZB)

STYRENE/ACRYLAMIDE CO PO LYMER ( 50 0 0 0 0 MW) (UNII: 5Z4DPO246 A)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:719 42-10 1-0 1

8 8 .7 mL in 1 BOX; Type 0 : No t a Co mbinatio n Pro duct

0 2/0 9 /20 18

2

NDC:719 42-10 1-0 3

49 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 4/0 9 /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 final

pa rt352

0 2/0 9 /20 18

Labeler -

Amavara, Inc (079636282)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

No rthwest Co smetic Labo rato ries LLC

9 29 5720 14

ma nufa c ture (719 42-10 1)

Revised: 4/2019

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