NDC | 71644-004-50, 71644-004-80 |
Set ID | 69342d1d-027a-410b-e053-2a91aa0a3512 |
Category | HUMAN OTC DRUG LABEL |
Packager | Cyberderm Laboratories Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- Apply liberally to face and body 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water-resistant sunscreen if swimming or sweating
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 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
- Children under 6 months of age: ask a doctor
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
Inactive ingredients water/eau, caprylic/capric triglyceride*, glyceryl isostearate*, polyhydroxystearic acid*, glyceryl stearate*, PEG-75 stearate, ceteth-20, steareth-20, glycerin*, cetyl dimethicone, methylcellulose, trisodium ethylenediame disuccinate, xanthan gum, sclerotium gum, caprylhydroxamic acid, caprylyl glycol, silica, PVP, chlorphenesin, cetyl alcohol, sodium citrate, phenoxyethanol, disodium EDTA, BHT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CYBERDERM EVERY MORNING SUN WHIP
zinc oxide, octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71644-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 15 g in 100 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) STEARETH-20 (UNII: L0Q8IK9E08) CHLORPHENESIN (UNII: I670DAL4SZ) BETASIZOFIRAN (UNII: 2X51AD1X3T) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) CETYL ALCOHOL (UNII: 936JST6JCN) SODIUM CITRATE (UNII: 1Q73Q2JULR) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) METHYLCELLULOSE (15 MPA.S) (UNII: NPU9M2E6L8) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-75 STEARATE (UNII: OT38R0N74H) CETETH-20 (UNII: I835H2IHHX) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71644-004-50 1 in 1 CARTON 03/30/2018 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:71644-004-80 1 in 1 CARTON 03/30/2018 2 80 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/30/2018 Labeler - Cyberderm Laboratories Inc. (242524267)