Label: CYBERDERM EVERY MORNING SUN WHIP- zinc oxide, octinoxate lotion
- NDC Code(s): 71644-004-50, 71644-004-80
- Packager: Cyberderm Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 January 11, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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
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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
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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 ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 15 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) METHYLCELLULOSE (15 MPA.S) (UNII: NPU9M2E6L8) 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) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-75 STEARATE (UNII: OT38R0N74H) CETETH-20 (UNII: I835H2IHHX) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) 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) 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)