SKIN FIRM LIPOAMINO HYDRATOR SPF 15 MOLTON BROWN- avobenzone, ensulizole, octinoxate, octocrylene lotion

Skin Firm Lipoamino hydrator SPF 15 by

Drug Labeling and Warnings

Skin Firm Lipoamino hydrator SPF 15 by is a Otc medication manufactured, distributed, or labeled by Molton Brown LTD, DDD LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients      Purpose

Avobenzone 3%           Sunscreen

Ensulizole 1%               Sunscreen

Octinoxate 5%             Sunscreen

Octocrylene 2%            Sunscreen

Use

UseProvides medium protection against sunburn

For skin highly sensitive to sunburn

warning

Keep out of reach of children

Indications

Stop use and ask a doctor if skin rash or irritation occurs

warnings

For external use only

Sun alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin ageing, skin cancer, and other harmful effects of the sun. 

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

If swallowed, get medical help or contact a poison control center right away.

Directions

Apply a small amount to your face and neck, morning and evening, after washing and shaving.

Inactive Ingredients

water, coconut alkanes, nylon 6/12, C12-15 alkyl benzoate, glycerin, olea europaea (olive) fruit oil, butyrospermum parkii (shea) butter, fragrance, chamaecyparis obtusa oil, lonicera caprifolium (honeysuckle) flower extract, lonicera japonica (honeysuckle) flower extract, sodium hyaluronate, coco-caprylate/caprate, dipalmitoyl hydroxyproline, sodium acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate, cetearyl olivate, sorbitan palmitate, cetyl palmitate, carbomer, tocopherol, propylene glycol, phenoxyethanol, methylisothiazolinone, thriethanolamine, citric acid.

PRINCIPAL DISPLAY PANEL

Molton Brown

Skin Firm Lipoamino

hydrator SPF15

Moisturizing Sunscreen

INGREDIENTS AND APPEARANCE

SKIN FIRM LIPOAMINO HYDRATOR SPF 15  MOLTON BROWN
avobenzone, ensulizole, octinoxate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68814-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCONUT ALKANES (UNII: 1E5KJY107T)
ENSULIZOLE (UNII: 9YQ9DI1W42)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
OLIVE OIL (UNII: 6UYK2W1W1E)
SHEA BUTTER (UNII: K49155WL9Y)
CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
CARBOMER 934 (UNII: Z135WT9208)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TROLAMINE (UNII: 9O3K93S3TK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68814-250-02	1 in 1 CARTON
1	NDC: 68814-250-01	50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2011

Labeler - Molton Brown LTD (769334822)

Registrant - Molton Brown LTD (769334822)

Establishment
Name	Address	ID/FEI	Business Operations
DDD LTD		216339804	manufacture(68814-250)