Coppertone Pure and Simple Baby SPF 50
- Manufacturer
- Bayer HealthCare LLC.
- Effective date
- 2019-12-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:54:36
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Octinoxate 7.5%, Octocrylene 10%, Zinc Oxide 15%
OTC - PURPOSE SECTION
Purpose
Sunscreen
INDICATIONS & USAGE SECTION
Uses
■ helps prevent sunburn
■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
WARNINGS SECTION
Warnings
For external use only
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin
OTC - WHEN USING SECTION
When using this product keep out of eyes. Rinse with water to remove.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash occurs
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
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
■ 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-sleeve shirts, pants, hats, and sunglasses
■ children under 6 months: Ask a doctor
Other information
Other information
■ protect this product from excessive heat and direct sun
■ may stain or damage some fabrics or surfaces
INACTIVE INGREDIENT SECTION
Inactive ingredients caprylic/capric triglyceride, ozokerite, theobroma cacao (cocoa) seed butter, lauryl laurate, bis-PEG-12 dimethicone beeswax, C12-15 alkyl benzoate, synthetic beeswax
OTC - QUESTIONS SECTION
Questions? 1-866-288-3330
Package label 13.9 g
Coppertone®
SUNSCREEN STICK
Pure &
Simple Baby®
+ cocoa butter
50
Hypoallergenic & gentle
No PABA, Parabens,
Phthalates,Fragrances,
Dyes, Oxybenzone
Water Resistant (80 Minutes)
Broad Spectrum
SPF 50
NET WT .49 OZ (13.9 g)
Products#
Every source-derived product name is available through these pages.
- Coppertone Pure and Simple Baby SPF 50
- octinoxate, octocrylene, zinc oxide
- OCTOCRYLENE
- ZINC OXIDE
- OCTINOXATE
- COCOA BUTTER
- ALKYL (C12-15) BENZOATE
- YELLOW WAX
- MEDIUM-CHAIN TRIGLYCERIDES
- CERESIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11523-7464 | 11523-7464-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| COCOA BUTTER | 512OYT1CRR | IACT |
| ALKYL (C12-15) BENZOATE | A9EJ3J61HQ | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| CERESIN | Q1LS2UJO3A | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9948fb67-5a13-4064-e053-2a95a90afb7a | 90772474-19e7-4bf9-e053-2995a90a8522 | 2019-12-09 | Warnings | 9948fb67-5a13-4064-e053-2a95a90afb7a 90772474-19e7-4bf9-e053-2995a90a8522 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
