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

Derma Soleil Natural Sunblock SPF 45 by

Drug Labeling and Warnings

Derma Soleil Natural Sunblock SPF 45 by is a Otc medication manufactured, distributed, or labeled by Derma Soleil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

• Octocrylene 7%
• Octyl Methoxycinnamate 7.5%,
• Octyl Salicylate 5%,
• Oxybenzone 6%

Purpose

Sunscreen

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

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

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)

PRINCIPAL DISPLAY PANEL - 240 ml Tube

Derma Soleil Health

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)

INGREDIENTS AND APPEARANCE

DERMA SOLEIL NATURAL SUNBLOCK SPF 45 
octocrylene, octyl methoxycinnamate, octyl salicylate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69711-458
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: 69711-458-01	120 mL in 1 TUBE; Type 0: Not a Combination Product	07/20/2017
2	NDC: 69711-458-02	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)