Label: BIG CLOUD DEFEND HYBRID FORMULA WITH ZINC- spf 30 sunscreen spray, suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 76150-244-48 - Packager: Bell International Laboratories, 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 May 1, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Uses
- Warnings
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Directions
Apply liberally and spread evenly by hand 15 minutes before sun exposure.
hold container 4 to 6 inches from the skin to apply.
do not spray directly onto face. Spray onto hands then apply to face
do not apply in windy conditions. Use in a well-ventilated area.
Reapply after 80 minutes of swimming or sweating, immediately after towel drying, and 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 wtih a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pm. Wear logn-sleeved shirts, pants, hats, and sunglasses.
Children under 6 months of age: Ask a doctor
- Other Information
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Inactive Ingredients
water, butyloctyl salicylate, methyl dihydroabietate, coconut alkanes, potassium cetyl phosphate, propanediol, microcrystalline cellulose, caprylyl glycol, fragrance, rubus ideaus (raspberry) seed oil, oryza sativa (rice) bran extract, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter, terminalia ferdinandiana fruit extract, rosmarinus officinalis (rosemary) leaf extract, opuntia vulgaris extract, helianthus annuus (sunflower) extract, tocopherol, cetearyl alcohol, glycerin, cetyl palmitate, sorbitan palmitate, triethoxycaprylylsilane, ethyl ferulate, sodium gluconate, bisabolol, cellulose gum, caprylylhydroxamic acid, sorbitan oleate, xanthan gum, coco-caprylate/caprate, sodium benzoate, potassium sorbate, citric acid, phenoxyethanol, Alpha-Isomethyl Ionone, Coumerin, Hydroxyitronellal, Linalool
- 6 oz can label
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INGREDIENTS AND APPEARANCE
BIG CLOUD DEFEND HYBRID FORMULA WITH ZINC
spf 30 sunscreen spray, suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76150-244 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.6 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.9 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 2.9 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5.3 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) LEVOMENOL (UNII: 24WE03BX2T) CETYL PALMITATE (UNII: 5ZA2S6B08X) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) RICE BRAN (UNII: R60QEP13IC) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) ALOE VERA LEAF (UNII: ZY81Z83H0X) PRICKLY PEAR FRUIT (UNII: 18V8PAQ629) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) RASPBERRY SEED OIL (UNII: 9S8867952A) PROPANEDIOL (UNII: 5965N8W85T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ROSEMARY (UNII: IJ67X351P9) TOCOPHEROL (UNII: R0ZB2556P8) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SHEA BUTTER (UNII: K49155WL9Y) SODIUM GLUCONATE (UNII: R6Q3791S76) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) XANTHAN GUM (UNII: TTV12P4NEE) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76150-244-48 170 g in 1 CAN; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/01/2020 Labeler - Bell International Laboratories, Inc. (967781555)
