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NDC 36800-0132-11 TOPCARE EVERYDAY ULTRA PROTECTION SPF 50 30; 100; 45; 80 mg/mL; mg/mL; mg/mL; mg/mL Details
TOPCARE EVERYDAY ULTRA PROTECTION SPF 50 30; 100; 45; 80 mg/mL; mg/mL; mg/mL; mg/mL
TOPCARE EVERYDAY ULTRA PROTECTION SPF 50 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by TOPCO ASSOCIATES LLC. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.
Product Information
| NDC | 36800-0132 |
|---|---|
| Product ID | 36800-132_c5601d2d-564f-367e-e053-2a95a90a6280 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | TOPCARE EVERYDAY ULTRA PROTECTION SPF 50 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 30; 100; 45; 80 |
| Active Ingredient Units | mg/mL; mg/mL; mg/mL; mg/mL |
| Substance Name | AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE |
| Labeler Name | TOPCO ASSOCIATES LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0132-11 (36800013211)
| NDC Package Code | 36800-132-11 |
|---|---|
| Billing NDC | 36800013211 |
| Package | 237 mL in 1 BOTTLE (36800-132-11) |
| Marketing Start Date | 2014-02-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c5601d22-2353-7319-e053-2a95a90a16c0 Details
Uses
Keep out of reach of children.
Directions
- apply liberally 15 minutes before sun exposure
- reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• 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 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
Other information
Inactive ingredients
water, polyester-7, neopentyl glycol diheptanoate, glycerin, styrene/acrylates copolymer, aluminum starch octenylsuccinate, silica, phenoxyethanol, isododecane, arachidyl alcohol, beeswax, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol (vitamin E), arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance
INGREDIENTS AND APPEARANCE
| TOPCARE EVERYDAY ULTRA PROTECTION SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion |
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| Labeler - TOPCO ASSOCIATES LLC (006935977) |
Revised: 6/2021
Document Id: c5601d2d-564f-367e-e053-2a95a90a6280
Set id: c5601d22-2353-7319-e053-2a95a90a16c0
Version: 1
Effective Time: 20210622