AUSTRALIAN GOLD BOTANICAL SUNSCREEN TINTED FACE 50 FOR FAIR TO LIGHT SKIN TONES- titanium dioxide, zinc oxide lotion

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

Buy It Now

Active ingredient:
Titanium Dioxide 4%, Zinc Oxide 4%
Available from:
Prime Enterprises 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.
Authorization status:
OTC monograph final
Authorization number:
58443-0273-3

AUSTRALIAN GOLD BOTANICAL SUNSCREEN TINTED FACE 50 FOR FAIR TO LIGHT

SKIN TONES- titanium dioxide, zinc oxide lotion

Prime Enterprises 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.

----------

Botanical Sunscreen TInted Face 50 BB Cream for Fair to Light Skin Tones

Active Ingredients

Titanium Dioxide 4%

Zinc Oxide 4%

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 product is swallowed, get medical help or contact a Poison Control

Center right away.

Directions

apply liberally 15 minutes before sun exposure

reapply:

after 80 minutes of swimming or sweating

immediately after towel drying

at least 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses

children under 6 months: Ask a doctor

Inactive ingredients

Cyclopentasiloxane, Water/Aqua/Eau, Glycerin, Silica, Cetyl PEG/PPG-10/1 Dimethicone,

Disteardimonium Hectorite, Polymethylsilsesquioxane, PEG-10 Dimethicone, Hexyl Laurate,

Polyglyceryl-4 Isostearate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Porphyra Umbilicalis

Extract, Eucalyptus Globulus (Eucalyptus) Leaf Extract, Dimethicone Crosspolymer, Stearic Acid,

Caprylyl Glycol, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Squalane, Panthenol,

Disodium EDTA, Triethoxycaprylylsilane, Alumina, Phenoxyethanol, Iron Oxides (CI 77492, CI 77491,

CI 77499)

Other information

Protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-855-LIV-GOLD (548-4653)

BOTANICAL SUNSCREEN TINTED FACE 50 BB CREAM FOR FAIR TO LIGHT SKIN

TONES

AUSTRALIAN GOLD BOTANICAL SUNSCREEN TINTED FACE 50 FOR FAIR

TO LIGHT SKIN TONES

titanium dioxide, zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:58 443-0 273

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

43.2 mg in 1 mL

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

TITANIUM DIOXIDE

43.2 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

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

TRIETHO XYCAPRYLYLSILANE (UNII: LDC331P0 8 E)

KAKADU PLUM (UNII: 0 ZQ1D2FDLI)

SQ UALANE (UNII: GW8 9 575KF9 )

PO LYMETHYLSILSESQ UIO XANE ( 4 .5 MICRO NS) (UNII: 59 Z9 0 7ZB6 9 )

PO RPHYRA UMBILICALIS (UNII: 14AN0 J70 WO)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

SHEA BUTTER (UNII: K49 155WL9 Y)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

CETYL PEG/PPG-10 /1 DIMETHICO NE ( HLB 2 ) (UNII: V2W71V8 T0 X)

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

DIMETHICO NE CRO SSPO LYMER ( 4 50 0 0 0 MPA.S AT 12 % IN CYCLO PENTASILO XANE) (UNII: UF76 20 L1W6 )

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

EUCALYPTUS GLO BULUS LEAF (UNII: S546 YLW6 E6 )

GLYCERIN (UNII: PDC6 A3C0 OX)

HEXYL LAURATE (UNII: 4CG9 F9 W0 1Q)

PANTHENO L (UNII: WV9 CM0 O6 7Z)

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

PEG-10 DIMETHICO NE ( 6 0 0 CST) (UNII: 8 PR7V1SVM0 )

WATER (UNII: 0 59 QF0 KO0 R)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO LYGLYCERYL-4 ISO STEARATE (UNII: 8 20 DPX33S7)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

Product Characteristics

Color

bro wn (Light Nude)

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:58 443-0 273-3

8 9 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /30 /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 8 /30 /20 19

Labeler -

Prime Enterprises Inc. (101946028)

Prime Enterprises Inc.

Labeler -

Prime Enterprises Inc. (101946028)

Registrant -

Prime Enterprises Inc. (101946028)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Prime Enterprises Inc.

10 19 46 0 28

pack(58 443-0 273) , manufacture(58 443-0 273) , label(58 443-0 273) , analysis(58 443-0 273)

Revised: 8/2019

Similar products

Search alerts related to this product

View documents history

Share this information