DERMA SOLEIL KIDS NATURAL SUNBLOCK SPF 45- octocrylene, octyl methoxycinnamate, octyl salicylate, oxybenzone lotion 
Derma Soleil

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.

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Derma Soleil Kids Natural Sunblock SPF 45

Drug Facts

Active Ingredients

Purpose

Sunscreen

Uses

Warnings

For external use only.

Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

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

Derma Soleil

Kids Natural Sunblock SPF 45
80% Natural

Moisturizing with Vitamins A, C, E & Aloe

UVA+UVB Protection
Water Resistant (40 minutes)
PABA Free

For All Skin Types

Broad Spectrum
SPF 45+

Net 4 fl. Oz (120 ml)

120 ml Tube

PRINCIPAL DISPLAY PANEL - 240 ml Tube

Derma Soleil

Kids Natural Sunblock SPF 45
80% Natural

Moisturizing with Vitamins A, C, E & Aloe

UVA+UVB Protection
Water Resistant (40 minutes)
PABA Free

For All Skin Types

Broad Spectrum
SPF 45+

Net 8 fl. Oz (240 ml)

240 ml Tube

DERMA SOLEIL KIDS NATURAL SUNBLOCK SPF 45 
octocrylene, octyl methoxycinnamate, octyl salicylate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69711-457
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69711-457-01120 mL in 1 TUBE; Type 0: Not a Combination Product07/20/2017
2NDC:69711-457-02240 mL in 1 TUBE; Type 0: Not a Combination Product07/20/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/20/2017
Labeler - Derma Soleil (079767886)

Revised: 7/2017
Document Id: 5512bc12-fe9e-1398-e054-00144ff88e88
Set id: 5512bc12-fe9d-1398-e054-00144ff88e88
Version: 1
Effective Time: 20170724
 
Derma Soleil