Label: PETER ISLAND CONTINOUS SUNSCREEN KIDS SPF 50- oxybenzone, avobenzone, octocrylene spray
-
Contains inactivated NDC Code(s)
NDC Code(s): 10056-710-34 - Packager: Access Business Group LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated July 9, 2013
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
-
Warnings
For external use only
Flammable: Do not Puncture or incinerate, Contents under pressure.Do not store at temperatures above 120 F. Do not use in the presence of a flame or spark. Keep away from sources of Ignition-No smoking.
-
DIRECTIONS:
- hold container 4-6 inches from the skin to apply
- spray liberally and spread evenlyb by hand 15 minutes before sun exposure
- Do not spray directly on face.
- Spray on hands then apply to face
- do not apply in windy conditionss
- use in well-ventiliated area
-
reapply: after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours.
Sun protection measures:
- Spending time in the sun increase your risk of skin cancer and early skin aging To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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 -sleeve shirts, pants, hats and sunglasses
- children under 6 months of age:
- Ask a doctor
- Other Information
- Uses
- Principal Display Panel
- Inactive Ingredients:
-
INGREDIENTS AND APPEARANCE
PETER ISLAND CONTINOUS SUNSCREEN KIDS SPF 50
oxybenzone, avobenzone, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10056-710 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CAPRYLYL GLYCOL (UNII: 00YIU5438U) MINERAL OIL (UNII: T5L8T28FGP) PEG-8 DIMETHICONE (UNII: GIA7T764OD) ALOE VERA LEAF (UNII: ZY81Z83H0X) OCTYLDODECANOL (UNII: 461N1O614Y) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10056-710-34 177 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/09/2013 Labeler - Access Business Group LLC (839830713)