DERMA SOLEIL NATURAL SUNBLOCK SPF 15- octocrylene,octyl methoxycinnamate,octyl salicylate,oxybenzone lotion

DERMA SOLEIL NATURAL SUNBLOCK SPF 15 by

Drug Labeling and Warnings

DERMA SOLEIL NATURAL SUNBLOCK SPF 15 by is a Otc medication manufactured, distributed, or labeled by Biological Health Group, Derma Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octocrylene 3%
Octyl Methoxycinnamate 6%,
Octyl Salicylate 3%,
Oxybenzone 4%

PURPOSE

Sunscreen

DOSAGE & ADMINISTRATION

WHEN USING

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.

ASK DOCTOR

DO NOT USE

KEEP OUT OF REACH OF CHILDREN

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.

INDICATIONS & USAGE

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

INACTIVE INGREDIENT

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

INGREDIENTS AND APPEARANCE

DERMA SOLEIL NATURAL SUNBLOCK SPF 15 
octocrylene,octyl methoxycinnamate,octyl salicylate,oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69711-904
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE SODIUM (UNII: MP1J8420LU)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
AVOCADO OIL (UNII: 6VNO72PFC1)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GRAPE SEED OIL (UNII: 930MLC8XGG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM ANISATE (UNII: F9WFJ28MV9)
JOJOBA OIL (UNII: 724GKU717M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
HYPROMELLOSES (UNII: 3NXW29V3WO)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69711-904-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2020
2	NDC: 69711-904-02	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/24/2020

Labeler - Biological Health Group (079767886)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Soleil		202617023	manufacture(69711-904)