MOISTURIZING SUNSCREEN SPF15 - oxybenzone lotion 
Shine & Pretty (USA), Corp.

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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For Sun protection: Apply on surfaces of skin, on face, arm and hand. SPF-15 provides the face and body skin with effective protection against harmful UVA and UVB rays. Use daily over moisture cream to help prevent premature aging and wrinkling due to prolonged exposure to the sun, reapply after swimming or excessive exercise.

Smear Lightly.

Warning: For external use only, not to be swallowed. Avoid contact with eye. Discontinue if signs of irritation or rash appear.

To Apply lightly.

Inactive Ingredients: SORBITAN SESQUIOLEATE, POLYSORBATE 60, CARBOMER 934, VITAMIN E ACETATE, STEARIC ACID, PROPYLENE GLYCOL, VITAMIN A PALMITATE, PROPYLPARABEN, Water.

Keep Out of the reach of children. Use on children under six months of age only with the advice of a physician.

OXYBENZONE and OCTINOXATE.

MM1label

MOISTURIZING SUNSCREEN SPF15 
oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59663-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1 mL  in 200 mL
Inactive Ingredients
Ingredient NameStrength
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CARBOMER 934 (UNII: Z135WT9208)  
VITAMIN E ACETATE (UNII: 9E8X80D2L0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59663-001-01100 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/02/1996
Labeler - Shine & Pretty (USA), Corp. (603528605)

Revised: 6/2011
Document Id: 887b89ab-92bf-4bfa-b6b3-73539f94255c
Set id: 3a0b9ac4-12c0-4ef9-a4e1-56c2ea21dc49
Version: 1
Effective Time: 20110602
 
Shine & Pretty (USA), Corp.