NDC | 65692-0201-1 |
Set ID | 76905526-dc55-46f0-b4a7-c910cf1297c6 |
Category | HUMAN OTC DRUG LABEL |
Packager | Raining Rose, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- PEEL HERE FOR DRUG FACTSBROAD SPECTRUN SPF 30 SunscreenVanilla Mint Lip Balm - 0201
- Purpose
- Uses
- Warnings
- Do not use
- Stop use and as a doctor if
- When using this product
- Keep out of reach of children.
-
Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months of age: Ask a doctor
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 protection measures including:
- limit time in the sun, s\especially from 10a.m. - 2p.m.
- wear long slessved shirts, pants, hat, and sunglasses.
- Inactive Ingredients:
- Other Information
- Vanilla Mint Lip Balm SPF 30 product label
-
INGREDIENTS AND APPEARANCE
VANILLA MINT LIP SPF 30 BALM
avobenzone, homosalate, octisalate, octocrylene, oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65692-0201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.12 g in 4.25 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.32 g in 4.25 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 0.21 g in 4.25 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.10 g in 4.25 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.25 g in 4.25 g Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) YELLOW WAX (UNII: 2ZA36H0S2V) OLIVE OIL (UNII: 6UYK2W1W1E) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) ROSEMARY (UNII: IJ67X351P9) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65692-0201-1 4.25 g in 1 CONTAINER; Type 0: Not a Combination Product 12/19/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/19/2016 Labeler - Raining Rose, Inc. (083819404) Registrant - Raining Rose, Inc. (083819404) Establishment Name Address ID/FEI Business Operations Raining Rose, Inc. 083819404 manufacture(65692-0201) , label(65692-0201) , relabel(65692-0201) , repack(65692-0201)