Label: BIG CLOUD DEFEND DAILY FACE MOISTURIZER BROAD SPECTRUM SPF30- avobenzone, homosalate and octocrylene lotion lotion
- NDC Code(s): 69522-2618-1, 69522-2618-2
- Packager: Dollar Shave Club, Inc.
- 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 January 12, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
• Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.
• 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 10 a.m. - 2 p.m., • wear long-sleeved shirts, pants, hats, and sunglasses. • Children under 6 months of age: Ask a doctor.
- Other Information
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Inactive Ingredients
Water, Neopentyl Glycol Diheptanoate, Diisopropyl Adipate, Ceteareth-6 Olivate, Glycerin, Butyloctyl Salicylate, Cetearyl Olivate, Polymethylsilsesquioxane, Butyrospermum Parkii (SHea) Butter, Aloe Barbadensis Leaf Juice, Terminalia Ferdinandiana Fruit Extract, Anogeissus Leiocarpa Bark Extract, Sorbitan Olivate, Caprylyl Glycol, Silica, Acrylates/C10-30 Alkyl acrylate Crosspolymer, Caprylhydroxamic Acid, Sodium Phytate, Xanthan Gum, Sodium Hydroxide, Citric Acid, Propanediol, Ethylhexylglycerin, Phenoxyethanol, Alpha-Isomethyl Ionone, Coumarin, Hydroxycitronellal, Linalool, Fragrance.
- Principle Display Panel
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INGREDIENTS AND APPEARANCE
BIG CLOUD DEFEND DAILY FACE MOISTURIZER BROAD SPECTRUM SPF30
avobenzone, homosalate and octocrylene lotion lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69522-2618 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 mg in 100 mg OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4.5 mg in 100 mg AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 mg in 100 mg Inactive Ingredients Ingredient Name Strength CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) XANTHAN GUM (UNII: TTV12P4NEE) FIG (UNII: TGD87RII2U) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) CETEARETH-6 OLIVATE (UNII: 8834VWF9MO) CETEARYL OLIVATE (UNII: 58B69Q84JO) MINT (UNII: FV98Z8GITP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ANOGEISSUS LEIOCARPUS BARK (UNII: U5TP1X38RH) SORBITAN OLIVATE (UNII: MDL271E3GR) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) KAKADU PLUM (UNII: 0ZQ1D2FDLI) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) COUMARIN (UNII: A4VZ22K1WT) LINALOOL, (+)- (UNII: F4VNO44C09) HEXASODIUM PHYTATE (UNII: ZBX50UG81V) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) PROPANEDIOL (UNII: 5965N8W85T) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) SHEA BUTTER (UNII: K49155WL9Y) Product Characteristics Color white (Off White to White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69522-2618-1 1 mg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 05/01/2020 2 NDC:69522-2618-2 1 mg in 1 TUBE; Type 0: Not a Combination Product 05/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/01/2020 Labeler - Dollar Shave Club, Inc. (004164494)
