GOLDIE LOCKS SHEER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- 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.

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Goldie Locks Sheer Mineral Sunscreen Broad Spectrum SPF 30

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?

Contact us via email at hello@goldielocks.com

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0574
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30.78 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30.78 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (Off White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0574-3100 mL in 1 TUBE; Type 0: Not a Combination Product06/23/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02006/23/2022
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0574) , manufacture(58443-0574) , label(58443-0574) , analysis(58443-0574)

Revised: 9/2022
Document Id: e81c7081-e8cc-e84d-e053-2995a90a9962
Set id: e81c7081-e8cb-e84d-e053-2995a90a9962
Version: 1
Effective Time: 20220907
 
Prime Enterprises Inc.