LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST BALM B5 UV SKIN PROTECTANT SUNSCREEN SOOTHING THERAPEUTIC MULTI-PURPOSE BROAD SPECTRUM SPF 50- dimethicone, homosalate, octisalate, octocrylene and zinc oxide cream

LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50 by

Drug Labeling and Warnings

LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50 by is a Otc medication manufactured, distributed, or labeled by L’Oreal USA Products Inc, L'OREAL USA PRODUCTS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Dimethicone 1%

Homosalate 8%

Octisalate 5%

Octocrylene 5%

Zinc oxide 7%

Purpose

Skin protectant

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

• temporarily protects chapped or cracked skin
• 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

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating.
• 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

Other information

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, glycerin, propanediol, butyloctyl salicylate, petrolatum, panthenol, dimethicone, butyrospermum parkii (shea) butter, steareth-20, cellulose, ethylhexyl methoxycrylene, polymnia sonchifolia root juice, oryza sativa (rice) bran wax, steareth-2, sorbitan isostearate, madecassoside, triethoxycaprylylsilane, alpha-glucan oligosaccharide, mannose, ammonium polyacryloyldimethyl taurate, hydroxyacetophenone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, lactobacillus, maltodextrin, pentylene glycol, polyhydroxystearic acid, polysorbate 60, C12-22 alkyl acrylate/hydroxyethyl acrylate copolymer, chlorphenesin

Questions or comments?

1-888-LRP-LABO 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST BALM B5 UV SKIN PROTECTANT SUNSCREEN SOOTHING THERAPEUTIC MULTI-PURPOSE BROAD SPECTRUM SPF 50 
dimethicone, homosalate, octisalate, octocrylene and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82046-992
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	10 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PETROLATUM (UNII: 4T6H12BN9U)
PANTHENOL (UNII: WV9CM0O67Z)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
STEARETH-20 (UNII: L0Q8IK9E08)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
POLYMNIA SONCHIFOLIA ROOT JUICE (UNII: M9S7HX36CT)
ORYZA SATIVA (RICE) BRAN (UNII: R60QEP13IC)
STEARETH-2 (UNII: V56DFE46J5)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALPHA-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
MANNOSE (UNII: PHA4727WTP)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID (UNII: 2968PHW8QP)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
LACTOBACILLUS (UNII: 5307V7XW8I)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82046-992-01	1 in 1 CARTON	04/01/2024
1		40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/01/2024

Labeler - L’Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA PRODUCTS, INC.		624244349	manufacture(82046-992)