Label: FRE PROTECT ME LIGHTWEIGHT DAILY MOISTURIZER SPF 50- zinc oxide cream
- NDC Code(s): 69435-1404-1
- Packager: Peer Pharm Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated February 9, 2023
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- Drug Facts
- Active Ingredients
- Uses
- Warnings
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Directions
• Shake well before use
- Apply liberally 15 minutes before sun exposure
- Reapply:
- After 40 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 a broad-spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10a.m. to 2p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses.
- Children under 6 months: ask a doctor
- Other information
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Inactive Ingredients
Water (Aqua), Coco-Caprylate, Glyceryl Oleate Citrate, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopherol, Argania Spinosa Kernel Oil, Polyhydroxystearic Acid, Panthenol, Triethoxycaprylylsilane, Lauryl Glucoside, Polyglyceryl-6 Laurate, Propanediol, Xanthan Gum, Myristyl Glucoside,Caprylic/Capric Triglyceride, Isomalt, Glycerin, Caprylyl Glycol, Lauroyl Lysine, Sodium Phytate, Argania Spinosa Leaf Extract,Ethylhexylglycerin, Caprylhydroxamic Acid, Citrus AurantiumBergamia (Bergamot) Fruit Oil, Cymbopogon Flexuosus Oil,Lavandula Angustifolia (Lavender) Oil, Carnosine, Argania Spinosa Callus Culture Extract, Lecithin.
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INGREDIENTS AND APPEARANCE
FRE PROTECT ME LIGHTWEIGHT DAILY MOISTURIZER SPF 50
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69435-1404 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 24 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCO-CAPRYLATE (UNII: 4828G836N6) GLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K) STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) XANTHAN GUM (UNII: TTV12P4NEE) PANTHENOL (UNII: WV9CM0O67Z) PROPANEDIOL (UNII: 5965N8W85T) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ISOMALT (UNII: S870P55O2W) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERIN (UNII: PDC6A3C0OX) MYRISTYL GLUCOSIDE (UNII: 6AK28695LF) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHYTATE SODIUM (UNII: 88496G1ERL) LAUROYL LYSINE (UNII: 113171Q70B) ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) TOCOPHEROL (UNII: R0ZB2556P8) BERGAMOT OIL (UNII: 39W1PKE3JI) EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW) LAVENDER OIL (UNII: ZBP1YXW0H8) CARNOSINE (UNII: 8HO6PVN24W) ARGAN OIL (UNII: 4V59G5UW9X) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69435-1404-1 1 in 1 CARTON 02/15/2023 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/15/2023 Labeler - Peer Pharm Ltd. (514678390) Registrant - Peer Pharm Ltd. (514678390) Establishment Name Address ID/FEI Business Operations Peer Pharm Ltd. 514678390 manufacture(69435-1404)
