NDC | 42421-802-16 |
Set ID | ed9bab86-2ad2-419e-8d38-9ccdea0b00bb |
Category | HUMAN OTC DRUG LABEL |
Packager | Emilia Personal Care Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
-apply liberally 15 minutes before sun exposure
-reapply at least every two hours
-use water resistant sunscreen if swimming or sweating
-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 witha Broad Spectrum SPF value 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-sleeved shirts, pants, hats and sunglasses
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CALLYSSEE BEAUTY FACEGUARD SKIN PROTECTING FACIAL BALM
avobenzone, homosalate, octisalate, octocrylene, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42421-802 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g in 50 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 50 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.5 g in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1 g in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 50 mL Inactive Ingredients Ingredient Name Strength ISOHEXADECANE (UNII: 918X1OUF1E) DIMETHICONE (UNII: 92RU3N3Y1O) BIS-ISOBUTYLENE PPG-20 (UNII: 5R9772B6IK) CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LEVOMENOL (UNII: 24WE03BX2T) ARABICA COFFEE BEAN (UNII: 3SW678MX72) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42421-802-16 50 mL in 1 TUBE; Type 0: Not a Combination Product 12/26/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/26/2016 Labeler - Emilia Personal Care Inc (965445112)