SKIN PROUD SERIOUS SHADE SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene emulsion 
Lottie London Limited

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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Skin Proud Serious Shade Sunscreen SPF 50

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen

Uses

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 physician

if rash occurs.

Keep out of reach of children.

If product is swallowed get medical help or contact a Poison Control Centre right away.

Directions

Other information

Inactive ingredients

Aqua (Water, Eau), Cocoglycerides, Silica, Cetyl Dimethicone, Peg-15 Cocamine, Stearyl Behenate, Glycerin, C12-15 Alkyl Benzoate, Peg-40 Stearate, Polyhydroxystearic Acid, Phenoxyethanol, Tocopheryl Acetate, Caprylyl Glycol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Parfum (Fragrance), Disodium Edta, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylhydroxamic Acid, Malpighia Punicifolia Fruit Extract, Spirulina Platensis Powder, Aloe Barbadensis Leaf Juice, Cetearyl Alcohol, Sodium Hydroxide, Ceramide Np, Limonene, Hexyl Cinnamal, Linalool, Geraniol, Citral.

Company Information

Made in Australia

Dist. by: Lottie London Limited, Batchworth House, Herts, WD3 1JE, UK Oxford Eireann, North Point House, Cork, T23AT2P, Ireland

www.iamproud.com

Product Packaging

skin proud

SKIN PROUD SERIOUS SHADE SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82803-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
PEG-15 COCAMINE (UNII: 8L6LB12TSJ)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CERAMIDE NP (UNII: 4370DF050B)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GERANIOL (UNII: L837108USY)  
CITRAL (UNII: T7EU0O9VPP)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
STEARYL BEHENATE (UNII: A68S9UI39D)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
MALPIGHIA GLABRA FRUIT (UNII: B94O42LA9M)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SPIRULINA PLATENSIS (UNII: 9L3TIH1UUE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82803-001-011 in 1 CARTON02/27/2023
140 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02002/27/2023
Labeler - Lottie London Limited (220466583)

Revised: 10/2022
Document Id: ebf2f7f8-1a14-1986-e053-2995a90a3982
Set id: ebf2f7f8-1a13-1986-e053-2995a90a3982
Version: 1
Effective Time: 20221026
 
Lottie London Limited