Label: CVS HEALTH BABY SPF 50 MINERAL-BASED SUN- octinoxate, octisalate, zinc oxide lotion
- NDC Code(s): 69842-178-11, 69842-178-22
- Packager: CVS Pharmacy
- 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 December 29, 2020
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
- children under 6 months: ask a doctor
- 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 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
- Other information
-
Inactive ingredients
water, propylene glycol, c12-15 alkyl benzoate, neopentyl glycol diheptanoate, cyclopentasiloxane, cetyl PEG/PPG-10/1 dimethicone, PEG-12 dimethicone crosspolymer, triethoxycaprylylsilane, aloe barbadensis leaf juice, ethylhexyl palmitate, diazolidinyl urea, methylparaben, propylparaben, sodium chloride
- CVS Health Baby SPF 50 Mineral Based Lotion
-
INGREDIENTS AND APPEARANCE
CVS HEALTH BABY SPF 50 MINERAL-BASED SUN
octinoxate, octisalate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-178 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 145 mg in 1 mL Inactive Ingredients Ingredient Name Strength NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) CYCLOMETHICONE 4 (UNII: CZ227117JE) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ETHYLHEXYL PALMITATE (UNII: 2865993309) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-178-22 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2018 2 NDC:69842-178-11 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/09/2018 Labeler - CVS Pharmacy (062312574)