Active Ingredients

Titanium Dioxide 3%

Zinc Oxide 3%

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 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

Alumina, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Dimethicone Crosspolymer, Disodium EDTA, Disteardimonium Hectorite, Eucalyptus Globulus Leaf Extract, Fragrance, Glycerin, Hexyl Laurate, Panthenol, PEG-10 Dimethicone, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polymethylsilsesquioxane, Porphyra Umbilicalis Extract, Silica, Squalane, Stearic Acid, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopheryl Acetate, Water

Other Information

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

Questions or Comments?

Goldie Locks Sheer Mineral Sunscreen Broad Spectrum SPF 30

Principle Display Label

GOLDIE LOCKS SHEER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0574
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	30.78 mg in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	30.78 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
ALUMINUM OXIDE (UNII: LMI26O6933)
SHEA BUTTER (UNII: K49155WL9Y)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALLANTOIN (UNII: 344S277G0Z)
CUCUMBER (UNII: YY7C30VXJT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LINSEED OIL (UNII: 84XB4DV00W)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)

Product Characteristics
Color	white (Off White)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0574-3	100 mL in 1 TUBE; Type 0: Not a Combination Product	06/23/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	06/23/2022

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises Inc.		101946028	pack(58443-0574) , manufacture(58443-0574) , label(58443-0574) , analysis(58443-0574)