Label: DERMA SOLEIL KIDS NATURAL SUNBLOCK SPF 45- octocrylene, octyl methoxycinnamate, octyl salicylate, oxybenzone lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 69711-457-01, 69711-457-02 - Packager: Derma Soleil
- 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 July 24, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
-
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
-
Directions
• 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 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • children under 6 months of age: ask a doctor -
Ingredients
Aloe Vera Gel, C12-15 Alkyl Benzoate, Aqua and Glycerin and Sodium Levulinate and Sodium Anisate, Fragrance, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Aminomethyl Propanol, Carbomer, Titanium Dioxide, Hydroxypropyl Methylcellulose, Tetrasodium EDTA, Evening Primrose Oil, Avocado Oil, Jojoba Oil, Grape Seed Oil, Blue Chamomile Oil, Calendula Oil, Hydrolyzed Wheat Protein, Retinyl Palmitate, Ascorbic Acid, Tocopherol Acetate.
- PRINCIPAL DISPLAY PANEL - 120 ml Tube
- PRINCIPAL DISPLAY PANEL - 240 ml Tube
-
INGREDIENTS AND APPEARANCE
DERMA SOLEIL KIDS NATURAL SUNBLOCK SPF 45
octocrylene, octyl methoxycinnamate, octyl salicylate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69711-457 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) EDETATE SODIUM (UNII: MP1J8420LU) EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) JOJOBA OIL (UNII: 724GKU717M) GRAPE SEED OIL (UNII: 930MLC8XGG) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) AVOCADO OIL (UNII: 6VNO72PFC1) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) WATER (UNII: 059QF0KO0R) SODIUM LEVULINATE (UNII: VK44E1MQU8) SODIUM ANISATE (UNII: F9WFJ28MV9) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) HYPROMELLOSES (UNII: 3NXW29V3WO) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ASCORBIC ACID (UNII: PQ6CK8PD0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69711-457-01 120 mL in 1 TUBE; Type 0: Not a Combination Product 07/20/2017 2 NDC:69711-457-02 240 mL in 1 TUBE; Type 0: Not a Combination Product 07/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/20/2017 Labeler - Derma Soleil (079767886)
